FDA Pushes Back PDUFA Date for Sarepta’s Eteplirsen

June 1, 2016

The FDA has pushed back the May 26 PDUFA date for Sarepta’s Duchenne muscular dystrophy treatment eteplirsen, the company announced last week.

According to Sarepta, the FDA is continuing its review and internal discussions related to the NDA and plans to make a decision “in as timely a manner as possible.”

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